A Study Comparing of Two Different Chemotherapy Regimens, in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer

• ClinicalTrials.gov Identifier: NCT00606021
• Recruitment Status: Completed
• First Posted: February 1, 2008
• Results First Posted: December 26, 2011
• Last Update Posted: December 26, 2011
• Sponsor: Eli Lilly and Company
• Information provided by (Responsible Party): Eli Lilly and Company

Tracking Information

• First Submitted Date: January 17, 2008
• First Posted Date: February 1, 2008
• Results First Submitted Date: October 3, 2011
• Results First Posted Date: December 26, 2011
• Last Update Posted Date: December 26, 2011
• Study Start Date: January 2008
• Actual Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 21, 2011)

Progression Free Survival During Maintenance Phase [ Time Frame: Randomization to progression of disease (PD) or date of death from any cause up to 30.9 months ]

Progression free survival is defined as the time from randomization until the date of progression of disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is ≥20% increase in sum of longest diameter of target lesions. PD in maintenance phase uses the last lesion assessment prior to randomization as the baseline assessment.

• Original Primary Outcome Measures (submitted: January 31, 2008): Progression free survival [ Time Frame: baseline at randomization to measured progressive disease ]

Current Secondary Outcome Measures (submitted: November 21, 2011)

• Progression Free Survival During Overall Period (Induction Phase [IP] + Maintenance Phase [MP]) [ Time Frame: First dose of study drug during IP to PD or date of death from any cause up to 33.6 months ]
  Progression-free survival in overall period is defined as the time from the date of first dose of study drug during IP until the date of PD or death from any cause. PD was determined using RECIST criteria. PD is ≥20% increase in sum of longest diameter of target lesions. PD in overall period uses the screening lesion assessment prior to the induction phase as the baseline assessment.
• Overall Survival During Maintenance Phase [ Time Frame: Randomization to PD or date of death from any cause up to 31.3 months ]
  Overall survival in maintenance phase is defined as the time from randomization to death. Participants who were alive were censored at the last contact.
• Overall Survival During Overall Period (IP + MP) [ Time Frame: First dose of study drug during IP to PD or date of death from any cause up to 34.1 months ]
  Overall survival in overall period is defined as the time from first dose of study drug during IP to death. Participants who were alive were censored at the last contact.
• Number of Participants With Adverse Events (AEs) During Overall Period [ Time Frame: First dose of study drug during IP through overall study completion (up to 34.3) months ]
  The list of serious adverse events (SAEs) and other non-serious adverse events (AEs) are in Adverse Events Section.
• Tumor Response Rate and Disease Control Rate After Induction Phase (IP) [ Time Frame: Randomization to measured PD up to 31.4 months ]
  Tumor response rate (%) is the number of responders (participants with best response of CR or PR) divided by the number of participants qualified for tumor response according to RECIST criteria multiplied by 100. Disease control rate is percentage of participants with a best response of stable disease [SD], PR, or CR. CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; PD is≥20% increase in sum of longest diameter of target lesions. SD= neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

Original Secondary Outcome Measures (submitted: January 31, 2008)

• Overall survival [ Time Frame: baseline at randomization to date of death from any cause and at 1 year ]
• Safety and adverse events [ Time Frame: Every cycle ]
• Tumor response rate & disease control rate after Induction Phase [ Time Frame: baseline to measured progressive disease ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study Comparing of Two Different Chemotherapy Regimens, in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer
• Official Title: A Randomized Phase 2 Study Comparing Pemetrexed Plus Best Supportive Care With Best Supportive Care as Maintenance, Following First-Line Treatment With Pemetrexed-Cisplatin, in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer

Brief Summary

This is a multicenter, open-label, randomized, two-arm Phase 2 study comparing pemetrexed plus best supportive care with best supportive care alone as maintenance therapy following first-line treatment with a pemetrexed-cisplatin combination in patients with advanced non-squamous non-small cell lung cancer.

A total of approximately 100 patients are planned to be enrolled, and following completion of four cycles of pemetrexed-cisplatin (Induction Phase) those patients in which disease progression has not occurred will be randomized in a 2:1 ratio to one of two treatment arms (Maintenance Phase): Arm A (pemetrexed plus best supportive care) or Arm B (best supportive care alone).

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Non Small Cell Lung Cancer

Intervention

• Drug: pemetrexed
  500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles
  Other Names:

  • Alimta
  • LY231514
• Drug: Best Supportive Care
  Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.

Study Arms

• Experimental: A: Pemetrexed + Best Supportive Care

  Pemetrexed: 500 milligrams per square meter (mg/m²) , intravenous (IV), Day 1 of each 21-day cycle for 6 cycles

  Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.

  Interventions:

  • Drug: pemetrexed
  • Drug: Best Supportive Care
• Active Comparator: B: Best Supportive Care
  Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
  Intervention: Drug: Best Supportive Care

• Publications *: Mubarak N, Gaafar R, Shehata S, Hashem T, Abigeres D, Azim HA, El-Husseiny G, Al-Husaini H, Liu Z. A randomized, phase 2 study comparing pemetrexed plus best supportive care versus best supportive care as maintenance therapy after first-line treatment with pemetrexed and cisplatin for advanced, non-squamous, non-small cell lung cancer. BMC Cancer. 2012 Sep 24;12:423. doi: 10.1186/1471-2407-12-423.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 6, 2011): 106
• Original Estimated Enrollment (submitted: January 31, 2008): 100
• Actual Study Completion Date: December 2010
• Actual Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion criteria:

1. You must be at least 18 years old
2. You must have been diagnosed with non-squamous non-small cell lung cancer (NSCLC)
3. You must have had no prior systemic anticancer therapy for lung cancer
4. You must live close enough to the study doctor to be able to visit regularly for follow up
5. You must have signed informed consent form indicating your willingness to take part in this study
6. Your laboratory and medical history and tests must meet study requirements

Exclusion criteria:

1. Treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
2. Prior radiotherapy and surgery should be completed at least 4 weeks prior to initiation of treatment
3. Serious concomitant systemic disorder (e.g., active infection including human immunodeficiency virus, or unstable cardiovascular disease)
4. Prior malignancy other than NSCLC, carcinoma in situ of the cervix, or nonmelanoma skin cancer unless treated at least 5 years previously with no subsequent evidence of recurrence
5. Brain metastasis
6. Presence of clinically significant (by physical exam) third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry
7. Significant weight loss (greater than 10%), over the previous 6 weeks before study entry
8. Concurrent administration of any other antitumor therapy
9. Inability to interrupt aspirin or other non-steroidal anti-inflammatory agents for a 5-day period (8-day period for long-acting agents such as piroxicam)
10. Inability or unwillingness to take folic acid, dexamethasone (or equivalent) or vitamin B12 supplementation
11. Pregnancy or breast-feeding
12. You are allergic to pemetrexed

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Egypt, Lebanon, Saudi Arabia

Administrative Information

• NCT Number: NCT00606021
• Other Study ID Numbers: 11839; H3E-EZ-S114 ( Other Identifier: Eli Lilly and Company )
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Eli Lilly and Company
• Study Sponsor: Eli Lilly and Company
• Collaborators: Not Provided

Investigators

• Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9am to 5pm Eastern Time (UTC/GMT - 5 hours, EST); Eli Lilly and Company

• PRS Account: Eli Lilly and Company
• Verification Date: November 2011